Application 091289
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TROSPIUM CHLORIDE | TROSPIUM CHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0591-3636 | Trospium Chloride | Trospium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 60429-098 | Trospium Chloride | Trospium Chloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 68001-228 | Trospium Chloride | Trospium Chloride | BluePoint Laboratories | ANDA | Current |
| 68001-228 | Trospium Chloride | Trospium Chloride | BluePoint Laboratories | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9331 | ORIG | 2012-10-15 |